(297 days)
Over-The-Counter Use:
TENS:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, arm,and leg, due to strain from exercise or normal household and work activities.
EMS/NMES:
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Prescription Use:
TENS:
1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
EMS/NMES:
1)Relaxation of muscle spasm;
2)Increase of local blood flow circulation;
3)Prevention or retardation of disuse atrophy;
4)Muscle re-education:
5)Maintaining or increasing range of motion;
6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Not Found
The provided text is an FDA 510(k) clearance letter for a Wireless TENS & EMS device. It does not contain information on the acceptance criteria, study details, or performance metrics often found in a clinical study report. Therefore, I cannot generate the requested table and answer the study-related questions based on this document.
The document primarily focuses on:
- The FDA's decision of substantial equivalence.
- The indications for use for the device.
- Regulatory information and requirements.
To answer your questions, I would need a clinical study report or a summary of safety and effectiveness data, which typically includes performance testing and results.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).